China NMPA Product Recall - Fully automated biochemical analyzer, fully automated biochemical immunoassay analyzer

Ortho-Clinical Diagnostics, Inc. (USA) initiated a recall on October 14, 2014, for its fully automated biochemical and immunoassay analyzers. This action, documented by the National Medical Products Administration (NMPA) on October 23, 2014, followed a report from Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. The primary issue identified was a potential calibration failure under specific conditions when using the barcode label accompanying the electrolyte and lipid composite calibrator with Analyzer Software Version 3.1. The company advised users to avoid employing the barcode label for calibrators until new software is installed, recommending manual programming calibration as an interim solution, with a new software version expected to resolve this anomaly. While the recall impacted regions including Canada, Denmark, Japan, Spain, and the USA, Ortho-Clinical Diagnostics clarified that the affected products were not sold in China. Furthermore, Analyzer Software Version 3.1, which exhibited the issue, was not in use within China. Consequently, Chinese regulatory bodies were instructed to enhance supervision of such products, though no direct product-related actions were required within China itself, as the affected products and software were not present in the Chinese market. This recall underscores the importance of rigorous quality control in medical device calibration.